Events

Rappel de EMPTYSTERILE I.V.SOLUTION TRANSFER CONTAINERS AND FILL/PUMP TUBING SETS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par HEALTHMARK SERVICES LTD..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    32294
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-07-06
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    Autocomp6 autocomp6 xp and autocomp6 xps high speed compounders may not be able to maintain the fill accuracy requirements for the compounded bags as outlined in the user's manual. therefore the patient receiving the compounded bag may both receive the correct quantity of individual parenteral nutrition solutions or the correct overall quantity of parenteral nutrition solutions.

Device

EMPTYSTERILE I.V.SOLUTION TRANSFER CONTAINERS AND FILL/PUMP TUBING SETS
  • Modèle / numéro de série
    Model Catalog: 58741 (Lot serial: ALL LOTS); Model Catalog: 58740 (Lot serial: ALL LOTS); Model Catalog: 58785 (Lot serial: ALL LOTS); Model Catalog: 66715 (Lot serial: ALL LOTS); Model Catalog: 66710 (Lot serial: ALL LOTS); Model Catalog: 66330 (Lot serial: ALL LOTS); Model Catalog: 66325 (Lot serial: ALL LOTS); Model Catalog: 58742 (Lot serial: ALL LOTS); Model Catalog: 58750 (Lot serial: ALL LOTS); Model Catalog: 58753 (Lot serial: ALL LOTS); Model Catalog: 58754 (Lot serial: ALL LOTS); Model Catalog: 58781 (Lot serial: ALL LOTS); Model Catalog: 66005 (Lot serial: ALL LOTS); Model Catalog: 66010 (Lot serial: ALL LOTS); Model Catalog: 66015 (Lot serial: ALL LOTS); Model Catalog: 66020 (Lot serial: ALL LOTS); Model Catalog: 66025 (Lot serial: ALL LOTS); Model Catalog: 66030 (Lot serial: ALL LOTS); Model Catalog: 66035 (Lot serial: ALL LOTS); Model Catalog: 66315 (Lot serial: ALL LOTS); Model Catalog: 66310 (Lot serial: ALL LOTS)
  • Description du dispositif
    EMPTYSTERILE I.V.SOLUTION TRANSFER CONTAINERS
  • Manufacturer
    HEALTHMARK SERVICES LTD.

Manufacturer

HEALTHMARK SERVICES LTD.
  • Adresse du fabricant
    ST. LAURENT
  • Source
    HC